SoClean2 Automated Supplemental Sleep Equipment Maintenance Systems Instructions

: June 16, 2024
: SoClean

Table of Contents

SoClean2 Automated Supplemental Sleep Equipment Maintenance Systems
Specifications
Product Usage Instructions
INSTRUCTION
FAQ
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

SoClean2 Automated Supplemental Sleep Equipment Maintenance Systems

Specifications

Product Name: SoClean2 (SC1200) and SoClean3 (SC1400) Automated Supplemental Sleep Equipment Maintenance Systems
UPC/UDI Number:
- SoClean2: UPC 187293000860
- SoClean3: UDI (01)00858242007147

Product Usage Instructions

Proper Set-Up
It is important to properly set up your SoClean device to ensure optimal performance and avoid potential risks. Follow the steps below for proper set- up:

Ensure that the device is placed on a stable surface near your sleep equipment.
Connect the device to a power source using the provided power cord.
Attach the hose and mask adapter to your sleep equipment according to the instructions provided in the user manual.
Turn on the device using the power button.

Detecting Improper Set-Up

If you suspect that your SoClean device is not properly set up, you can check for the following signs:

The device does not turn on.
You detect a strong smell of ozone.

If you experience any of these signs, refer to the updated user manual for troubleshooting instructions or contact Customer Care for assistance.

Usage Precautions

It is important to take note of the following precautions before using the SoClean2 or SoClean3:

Persons with underlying lung diseases, such as asthma and chronic obstructive pulmonary disease (COPD), as well as those with cardiovascular disease, should consult with their healthcare professional before using the device.
Risks from ozone exposure may include cough, difficulty breathing, nasal irritation, headaches, asthma attacks, or other breathing issues. If you experience any of these symptoms while using the device, discontinue use and consult with a healthcare professional.

INSTRUCTION

The Purpose of this Letter
The purpose of this letter is to advise you that SoClean is conducting a voluntary field action intended to update and clarify the user manuals for all units of the SoClean2 and SoClean3. This voluntary field correction does not require you to stop using or return your

SoClean unit.
The Reason for Voluntary Field Correction
SoClean has received approximately 7,417 complaints (equating to 0.33% of all SoClean2 and SoClean3 units sold) resulting from improper set-up, unauthorized device modifications, and use by individuals for whom the device is not recommended as indicated in the user manual. Of those complaints, 334 (0.015%) were FDA-reportable adverse events and zero (0) deaths were reported.

Common complaints include (i) the customer not being able to set up or turn on the device; (ii) mildew smell in the hose; (iii) excessive ozone smell; (iv) cough; and (v) exacerbation of preexisting condition(s).
As stated in the user manual, persons with underlying lung diseases, such as asthma and chronic obstructive pulmonary disease (also known as COPD, which includes emphysema and chronic bronchitis), and those with cardiovascular disease, may be sensitive to ozone and should consult with their health care professional before using a SoClean2 or SoClean3.

SoClean is revising its labeling to incorporate: (i) additional warnings and contraindications; and (ii) proper and consistent device set-up instructions including use of a hose and mask adapter, thereby reducing potential risks associated with the previous device design and labeling.

Risk to Health
Risks from ozone exposure may include cough, difficulty breathing, nasal irritation, headaches, asthma attacks or other breathing issues.

Actions Taken by SoClean
SoClean is revising the existing labeling to provide clarifying instructions for both the SoClean2 and SoClean3, as follows:

Incorporated additional warnings and set-up instructions to enable appropriate use.
Additional instructions for events in which a user is unable to smell residual ozone.
Additional clarity and consistency regarding that the SoClean2 and SoClean3 are not intended to replace CPAP manufacturers’ cleaning instructions but rather are to be used to supplement cleaning procedures for home use CPAP masks and tubing.
With each SoClean filter purchase, SoClean is supplying a complementary (no additional cost) Hose and Mask Adapter, which facilitates use of the SoClean2 and SoClean3 equipment without ozone entering the CPAP. Set-up Instructions for the Hose and Mask Adapter are included in the updated manuals.

How to recognize if the device is not properly set up
Note that improper set-up of your SoClean can be detected by the machine not turning on and/or the smell of ozone. As noted above, the updated manuals contain instructions for users that are unable to smell ozone.

Products Affected

Product	UPC/UDI Number
SoClean2	UPC 187293000860
SoClean3	UDI (01)00858242007147

Actions to be Taken by You

User Manuals: Download the new version of the User Manual using the following links:
SoClean2
SoClean3
To obtain a paper copy of the new version of the user manual, simply contact Customer Care at 866-501-3705.

As noted above, this voluntary field correction does not require you to stop using or return your SoClean unit. Instructions for next steps are provided below.

Hose and Mask Adapter:
If you recently purchased a SoClean filter and only want to obtain a no cost Hose and Mask Adapter, please contact our Customer Care team at 866-501-3705 or visit the SoClean website: https://www.soclean.com/field-correction

Confirmation of Receipt. please go to the following link to acknowledge that you’ve read and understand this communication.

This notification is being performed with the knowledge of the Food and Drug Administration (FDA) and other appropriate regulatory authorities.
We at SoClean understand that your time is valuable. Therefore, after acknowledging this communication by following the link above, you will be supplied an offer code to receive 20% off your next SoClean filter purchase.
Adverse events or quality problems associated with the use of SoClean 2 and SoClean 3 may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download the form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

FAQ

FAQ (Frequently Asked Questions)

Q: Do I need to stop using or return my SoClean unit?
- A: No, this voluntary field correction does not require you to stop using or return your SoClean unit. The purpose of the correction is to update and clarify the user manuals for all units of SoClean2 and SoClean3.
Q: How can I obtain a paper copy of the new version of the user manual?
- A: To obtain a paper copy of the new version of the user manual, simply contact Customer Care at 866-501-3705.
Q: I recently purchased a SoClean filter. How can I obtain a no-cost Hose and Mask Adapter?
- A: If you recently purchased a SoClean filter and only want to obtain a no-cost Hose and Mask Adapter, please contact our Customer Care team at 866-501-3705 or visit the SoClean website: https://www.soclean.com/field-correction.
Q: How can I report any issues or complaints?
- A: If you wish to report any issues or complaints regarding yourSoClean2 or SoClean3, you can request a reporting form by calling 1088 or submit it by fax to 1-800-FDA-0178.